Trial Outcomes & Findings for National Cooperative Growth Study (NCGS): A Post-marketing Surveillance Program for Nutropin, Nutropin AQ, Nutropin Depot, and Protropin (NCT NCT00097539)

NCT ID: NCT00097539

Last Updated: 2017-02-15

Results Overview

Recruitment status

COMPLETED

Target enrollment

65205 participants

Primary outcome timeframe

From October 1985 to June 2010 (overall approximately 24 years and 9 months)

Results posted on

2017-02-15

Participant Flow

All participants were assigned to a growth failure etiology group. Assignment was determined from etiology and medical history data and comments from all participant forms. Etiology groups were mutually exclusive. Participants with multiple etiologies were prioritized as follows: Turner, Renal, Other, Organic GHD, IGHD, ISS, and Undefined.

Participant milestones

Participant milestones
Measure	Idiopathic Growth Hormone Deficiency (IGHD) Participants with IGDH who initiated therapy with Growth Hormone (GH) products (somatrem for injection \[Protropin\], somatropin for injection \[Nutropin, Nutropin AQ, and Nutropin Depot\]) and who consented to participate in the National Cooperative Growth Study (NCGS) were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. IGDH etiology group included participants with: Documented IGHD (a maximum GH stimulation test result of less than 10 nanograms per milliliter \[ng/mL\], coupled with a specific diagnosis of IGHD or equivalent condition by the attending physician; Undocumented IGHD (a stimulation test results were not available, but had a physician diagnosis specifically stated as IGHD or equivalent condition in text); or Presumed IGHD (a stimulation result of less than 10 ng/mL, coupled with the absence of any identifiable criterion for assignation to another etiology grouping).	Organic Growth Hormone Deficiency (GHD) Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Organic GHD etiology group included participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, central nervous system (CNS) tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.	Idiopathic Short Stature (ISS) Participants with ISS who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Participants must have had a stimulation result of greater than or equal to (\>/=) 10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of \>/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of \>/=10 ng/mL.	Turner Syndrome Participants with Turner Syndrome who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.	Renal Disease Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Renal etiology group included participants with chronic renal insufficiency (CRI) or End Stage Renal Disease (ESRD) prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.	Other Etiology Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. The other etiology group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.	Undefined Etiology Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
Overall Study STARTED	27286	9356	12519	5651	2144	8010	239
Overall Study COMPLETED	8220	2825	3411	2066	386	2118	68
Overall Study NOT COMPLETED	19066	6531	9108	3585	1758	5892	171

Reasons for withdrawal

Reasons for withdrawal
Measure	Idiopathic Growth Hormone Deficiency (IGHD) Participants with IGDH who initiated therapy with Growth Hormone (GH) products (somatrem for injection \[Protropin\], somatropin for injection \[Nutropin, Nutropin AQ, and Nutropin Depot\]) and who consented to participate in the National Cooperative Growth Study (NCGS) were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. IGDH etiology group included participants with: Documented IGHD (a maximum GH stimulation test result of less than 10 nanograms per milliliter \[ng/mL\], coupled with a specific diagnosis of IGHD or equivalent condition by the attending physician; Undocumented IGHD (a stimulation test results were not available, but had a physician diagnosis specifically stated as IGHD or equivalent condition in text); or Presumed IGHD (a stimulation result of less than 10 ng/mL, coupled with the absence of any identifiable criterion for assignation to another etiology grouping).	Organic Growth Hormone Deficiency (GHD) Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Organic GHD etiology group included participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, central nervous system (CNS) tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.	Idiopathic Short Stature (ISS) Participants with ISS who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Participants must have had a stimulation result of greater than or equal to (\>/=) 10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of \>/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of \>/=10 ng/mL.	Turner Syndrome Participants with Turner Syndrome who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.	Renal Disease Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Renal etiology group included participants with chronic renal insufficiency (CRI) or End Stage Renal Disease (ESRD) prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.	Other Etiology Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. The other etiology group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.	Undefined Etiology Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
Overall Study Status Unknown (Or no final evaluation)	11959	3948	5646	2170	1106	3546	108
Overall Study Withdrawal by Subject	925	323	346	217	68	229	3
Overall Study Participant Non-compliant	2140	567	1067	353	136	543	18
Overall Study Lack of Efficacy	249	122	202	105	45	228	5
Overall Study Adverse Event	78	133	37	27	30	59	1
Overall Study Death	2	7	0	0	1	3	0
Overall Study Reasons Other Than Above	3602	1382	1757	692	361	1244	34
Overall Study Reason not Specified	111	49	53	21	11	40	2

Baseline Characteristics

Here, 'Number Analyzed' signifies the number of participants with available Age data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Idiopathic Growth Hormone Deficiency (IGHD) n=27286 Participants Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.	Organic GHD n=9356 Participants Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.	Idiopathic Short Stature (ISS) n=12519 Participants Participants must have had a stimulation result of \>/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of \>/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of \>/=10 ng/mL.	Turner Syndrome n=5651 Participants Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.	Renal Disease n=2144 Participants Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.	Other Etiology n=8010 Participants The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.	Undefined Etiology n=239 Participants A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.	Total n=65205 Participants Total of all reporting groups
Age, Continuous	11.6 years n=27278 Participants • Here, 'Number Analyzed' signifies the number of participants with available Age data.	10.0 years n=9352 Participants • Here, 'Number Analyzed' signifies the number of participants with available Age data.	11.8 years n=12514 Participants • Here, 'Number Analyzed' signifies the number of participants with available Age data.	10.2 years n=5651 Participants • Here, 'Number Analyzed' signifies the number of participants with available Age data.	10.2 years n=2143 Participants • Here, 'Number Analyzed' signifies the number of participants with available Age data.	10.1 years n=8009 Participants • Here, 'Number Analyzed' signifies the number of participants with available Age data.	10.7 years n=239 Participants • Here, 'Number Analyzed' signifies the number of participants with available Age data.	11.1 years n=65186 Participants • Here, 'Number Analyzed' signifies the number of participants with available Age data.
Gender Female	6704 Participants n=27286 Participants	3426 Participants n=9356 Participants	3213 Participants n=12519 Participants	5651 Participants n=5651 Participants	630 Participants n=2144 Participants	3017 Participants n=8010 Participants	81 Participants n=239 Participants	22722 Participants n=65205 Participants
Gender Male	20582 Participants n=27286 Participants	5930 Participants n=9356 Participants	9306 Participants n=12519 Participants	0 Participants n=5651 Participants	1514 Participants n=2144 Participants	4993 Participants n=8010 Participants	158 Participants n=239 Participants	42483 Participants n=65205 Participants

PRIMARY outcome

Timeframe: From October 1985 to June 2010 (overall approximately 24 years and 9 months)

Population: Safety evaluable population

Outcome measures

Outcome measures
Measure	Idiopathic Growth Hormone Deficiency (IGHD) n=27286 Participants Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.	Organic GHD n=9356 Participants Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.	Idiopathic Short Stature (ISS) n=12519 Participants Participants must have had a stimulation result of \>/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of \>/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of \>/=10 ng/mL.	Turner Syndrome n=5651 Participants Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.	Renal Disease n=2144 Participants Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.	Other Etiology n=8010 Participants The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.	Undefined Etiology n=239 Participants A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
Number of Participants Who Died	14 participants	96 participants	4 participants	7 participants	23 participants	38 participants	1 participants

PRIMARY outcome

Timeframe: Year 1

Population: Safety evaluable population. Here, 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable for specified category.

Annualized growth rates are expressed as centimeters per year (cm/yr), computed as the change in height (centimeters) divided by the change in age (years). Growth rates were calculated from the date of the first injection (baseline/ enrollment) to the visit closest to 365\*1 days after baseline. Visits within 90 days of 365\*1 days after baseline may be used. If multiple visits within 90 days were reported then the visit closest to 365\*1 days was used. Growth rates less than (\<) -1 or greater than (\>) 30 cm/yr were excluded. Growth rates from -1 to 0 were set to 0 cm/yr. Growth rates are summarized by etiology group and gender. Only those participants who had non-missing 1-year growth rate data were included in the analysis.

Outcome measures

Outcome measures
Measure	Idiopathic Growth Hormone Deficiency (IGHD) n=8715 Participants Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.	Organic GHD n=3357 Participants Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.	Idiopathic Short Stature (ISS) n=3910 Participants Participants must have had a stimulation result of \>/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of \>/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of \>/=10 ng/mL.	Turner Syndrome n=2762 Participants Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.	Renal Disease n=715 Participants Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.	Other Etiology n=2940 Participants The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.	Undefined Etiology n=73 Participants A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
First Year Annualized Growth Rate Male	9.5 cm/yr Standard Deviation 2.7	10.3 cm/yr Standard Deviation 4.1	8.6 cm/yr Standard Deviation 2.2	—	8.9 cm/yr Standard Deviation 3.6	9.5 cm/yr Standard Deviation 3.5	9.8 cm/yr Standard Deviation 4.3
First Year Annualized Growth Rate Female	9.8 cm/yr Standard Deviation 3.2	11.0 cm/yr Standard Deviation 4.8	8.7 cm/yr Standard Deviation 2.5	8.0 cm/yr Standard Deviation 2.2	8.4 cm/yr Standard Deviation 3.4	9.4 cm/yr Standard Deviation 3.8	9.1 cm/yr Standard Deviation 2.5

PRIMARY outcome

Timeframe: Year 2

Annualized growth rates are expressed as cm/yr, computed as the change in height (centimeters) divided by the change in age (years). Growth rates were calculated from the date of the visit closest to 365 days after baseline to the visit closest to 730 days. Visits within 90 days of 365 and 730 days after baseline may be used. If multiple visits within 90 days were reported then the visit closest to 365 or 730 days was used. Growth rates \<-1 or \>30 cm/yr were excluded. Growth rates from -1 to 0 were set to 0 cm/yr. Growth rates are summarized by etiology group and gender. Only those participants who had non-missing second-year growth rate data were included in the analysis.

Outcome measures

Outcome measures
Measure	Idiopathic Growth Hormone Deficiency (IGHD) n=4980 Participants Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.	Organic GHD n=2094 Participants Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.	Idiopathic Short Stature (ISS) n=2090 Participants Participants must have had a stimulation result of \>/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of \>/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of \>/=10 ng/mL.	Turner Syndrome n=1790 Participants Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.	Renal Disease n=371 Participants Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.	Other Etiology n=1761 Participants The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.	Undefined Etiology n=40 Participants A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
Second Year Annualized Growth Rate Male	7.7 cm/yr Standard Deviation 1.8	8.0 cm/yr Standard Deviation 2.5	7.3 cm/yr Standard Deviation 1.6	—	7.2 cm/yr Standard Deviation 2.4	7.5 cm/yr Standard Deviation 2.2	7.7 cm/yr Standard Deviation 2.4
Second Year Annualized Growth Rate Female	8.0 cm/yr Standard Deviation 2.2	8.2 cm/yr Standard Deviation 2.8	7.3 cm/yr Standard Deviation 1.7	6.6 cm/yr Standard Deviation 1.5	7.2 cm/yr Standard Deviation 2.1	7.6 cm/yr Standard Deviation 2.4	8.0 cm/yr Standard Deviation 2.3

PRIMARY outcome

Timeframe: Year 3

Annualized growth rates are expressed as cm/yr, computed as the change in height (centimeters) divided by the change in age (years). Growth rates were calculated from the date of the visit closest to 730 days after baseline to the visit closest to 1095 days. Visits within 90 days of 730 and 1095 days after baseline may be used. If multiple visits within 90 days were reported then the visit closest to 730 or 1095 days was used. Growth rates \<-1 or \>30 cm/yr were excluded. Growth rates from -1 to 0 were set to 0 cm/yr. Growth rates are summarized by etiology group and gender. Only those participants who had non-missing third-year growth rate data were included in the analysis.

Outcome measures

Outcome measures
Measure	Idiopathic Growth Hormone Deficiency (IGHD) n=3314 Participants Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.	Organic GHD n=1581 Participants Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.	Idiopathic Short Stature (ISS) n=1205 Participants Participants must have had a stimulation result of \>/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of \>/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of \>/=10 ng/mL.	Turner Syndrome n=1290 Participants Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.	Renal Disease n=211 Participants Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.	Other Etiology n=1210 Participants The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.	Undefined Etiology n=28 Participants A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
Third Year Annualized Growth Rate Male	7.0 cm/yr Standard Deviation 1.7	7.1 cm/yr Standard Deviation 2.2	6.6 cm/yr Standard Deviation 1.6	—	6.2 cm/yr Standard Deviation 2.4	6.8 cm/yr Standard Deviation 1.9	6.5 cm/yr Standard Deviation 1.7
Third Year Annualized Growth Rate Female	7.1 cm/yr Standard Deviation 1.7	7.2 cm/yr Standard Deviation 2.3	6.7 cm/yr Standard Deviation 1.7	5.9 cm/yr Standard Deviation 1.5	6.1 cm/yr Standard Deviation 2.2	6.8 cm/yr Standard Deviation 1.9	6.3 cm/yr Standard Deviation 2.6

PRIMARY outcome

Timeframe: From October 1985 to June 2010 (overall approximately 24 years and 9 months)

Heights were standardized with height standardized deviation scores (SDS) to enable height comparisons across ages and sexes using methods and height standards found at: http://www.cdc.gov/growthcharts/cdc\_charts.htm. NAH were calculated overall and by etiology groups for participants who had both a non-missing value available height z-score and a non-missing enrollment height (EH) SDS, as well as for participants with 3 or more years of GH therapy (GHT ≥3y).

Outcome measures

Outcome measures
Measure	Idiopathic Growth Hormone Deficiency (IGHD) n=4828 Participants Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.	Organic GHD n=2352 Participants Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.	Idiopathic Short Stature (ISS) n=1976 Participants Participants must have had a stimulation result of \>/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of \>/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of \>/=10 ng/mL.	Turner Syndrome n=1940 Participants Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.	Renal Disease n=208 Participants Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.	Other Etiology n=1494 Participants The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.	Undefined Etiology n=37 Participants A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
Near Adult Height (NAH) EH	-2.5 SDS Standard Deviation 1.0	-2.4 SDS Standard Deviation 1.4	-2.7 SDS Standard Deviation 0.8	-3.1 SDS Standard Deviation 0.9	-3.1 SDS Standard Deviation 1.3	-2.9 SDS Standard Deviation 1.4	-3.0 SDS Standard Deviation 1.7
Near Adult Height (NAH) NAH GHT ≥3y	-0.8 SDS Standard Deviation 1.0	-1.0 SDS Standard Deviation 1.4	-1.1 SDS Standard Deviation 1.0	-1.9 SDS Standard Deviation 1.0	-1.7 SDS Standard Deviation 1.4	-1.5 SDS Standard Deviation 1.3	-1.2 SDS Standard Deviation 1.2
Near Adult Height (NAH) EH GHT ≥3y	-2.6 SDS Standard Deviation 1.0	-2.5 SDS Standard Deviation 1.4	-2.7 SDS Standard Deviation 0.8	-3.2 SDS Standard Deviation 1.0	-3.1 SDS Standard Deviation 1.2	-3.0 SDS Standard Deviation 1.4	-3.2 SDS Standard Deviation 1.8
Near Adult Height (NAH) NAH	-0.9 SDS Standard Deviation 1.1	-1.1 SDS Standard Deviation 1.4	-1.2 SDS Standard Deviation 1.0	-2.0 SDS Standard Deviation 1.0	-2.0 SDS Standard Deviation 1.5	-1.5 SDS Standard Deviation 1.3	-1.3 SDS Standard Deviation 1.2

Adverse Events

Idiopathic Growth Hormone Deficiency (IGHD)

Serious events: 322 serious events

Other events: 949 other events

Deaths: 0 deaths

Organic GHD

Serious events: 595 serious events

Other events: 523 other events

Deaths: 0 deaths

Idiopathic Short Stature (ISS)

Serious events: 100 serious events

Other events: 385 other events

Deaths: 0 deaths

Turner Syndrome

Serious events: 119 serious events

Other events: 328 other events

Deaths: 0 deaths

Renal Disease

Serious events: 141 serious events

Other events: 101 other events

Deaths: 0 deaths

Other Etiology

Serious events: 255 serious events

Other events: 357 other events

Deaths: 0 deaths

Undefined Etiology

Serious events: 4 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Idiopathic Growth Hormone Deficiency (IGHD) n=27286 participants at risk Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.	Organic GHD n=9356 participants at risk Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.	Idiopathic Short Stature (ISS) n=12519 participants at risk Participants must have had a stimulation result of \>/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of \>/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of \>/=10 ng/mL.	Turner Syndrome n=5651 participants at risk Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.	Renal Disease n=2144 participants at risk Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.	Other Etiology n=8010 participants at risk The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.	Undefined Etiology n=239 participants at risk A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
General disorders Malaise	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 7/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Optic nerve disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Tachycardia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Ventricular fibrillation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Mass	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Supraventricular tachycardia	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Anaemia	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.14% 3/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Aplasia pure red cell	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Aplastic anaemia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Blood disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Haemolysis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Leukaemoid reaction	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Lymphadenopathy	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Lymphocytosis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Lymphoid tissue hyperplasia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Neutropenia	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Thrombocytopenia	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Thrombocytopenic purpura	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Thymus enlargement	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Aortic valve incompetence	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Arrhythmia	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Arteriospasm coronary	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Atrial fibrillation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Atrioventricular block complete	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Bradycardia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Cardiac arrest	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 5/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Cardiac disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Cardiac failure	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Cardiac failure congestive	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Cardiac septal hypertrophy	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Cardiac tamponade	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Cardiac valve disease	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Cardiomyopathy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Cardiovascular disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Cyanosis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Left ventricular failure	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Left ventricular hypertrophy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Mitral valve incompetence	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Mitral valve prolapse	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Myocardial infarction	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Myocarditis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Palpitations	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Pericardial effusion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 4/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Pericarditis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Right ventricular failure	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Right ventricular hypertrophy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Adenomatous polyposis coli	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Arnold-chiari malformation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Arteriovenous malformation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Atrial septal defect	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Basal cell naevus syndrome	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Caudal regression syndrome	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Cerebral palsy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Cleft palate	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Coarctation of the aorta	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 4/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Congenital aplastic anaemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Cryptorchism	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Cystic fibrosis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders De Lange's syndrome	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Developmental hip dysplasia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders DiGeorge's syndrome	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Glycogen storage disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Gonadal dysgenesis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Hydrocele	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Hypertrophic cardiomyopathy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Hypochondroplasia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Low set ears	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders MELAS syndrome	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Macrogenia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Muscular dystrophy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Patent ductus arteriosus	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Pectus carinatum	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Pectus excavatum	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Rathke's cleft cyst	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Retinitis pigmentosa	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Septo-optic dysplasia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Spina bifida	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Spondyloepiphyseal dysplasia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Syringomyelia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Ear and labyrinth disorders Deafness	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Ear and labyrinth disorders Ear canal erythema	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Ear and labyrinth disorders Ear disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Ear and labyrinth disorders Ear pain	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Ear and labyrinth disorders Hearing impaired	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Ear and labyrinth disorders Hypoacusis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Ear and labyrinth disorders Otorrhoea	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Ear and labyrinth disorders Vertigo	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Acromegaly	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Adrenal insufficiency	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Adrenocortical insufficiency acute	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 7/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Autoimmune thyroiditis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Basedow's disease	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Diabetes insipidus	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Glucocorticoid deficiency	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Goitre	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Hyperparathyroidism	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Hypogonadism	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Hypoparathyroidism	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Hypopituitarism	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Hypothyroidism	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Parathyroid disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Precocious puberty	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Testicular failure primary	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Thyroid cyst	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Virilism	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Amblyopia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Multi-organ failure	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Blindness	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Cataract	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Choroidal neovascularisation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Diplopia	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Eye disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Eye pain	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Eyelid ptosis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Glaucoma	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Idiopathic orbital inflammation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Iris cyst	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Keratoconus	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Myopia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Ocular vascular disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Optic atrophy	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Optic discs blurred	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Panophthalmitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Papilloedema	0.04% 10/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 5/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.11% 6/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.19% 4/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Photophobia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Retinal detachment	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Retinal haemorrhage	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Retinopathy proliferative	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Strabismus	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Vision blurred	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Visual acuity reduced	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Visual impairment	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Abdominal distension	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Abdominal pain	0.02% 5/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 5/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Abdominal pain lower	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Abdominal pain upper	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Acute abdomen	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Anal fistula	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Anorectal disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Breath odour	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Colitis	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Colitis ulcerative	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Constipation	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Crohn's disease	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Diarrhoea	0.03% 7/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 7/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.19% 4/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Duodenal perforation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Dysphagia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Enamel anomaly	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Faeces discoloured	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Faeces hard	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Gastric perforation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Gastric ulcer	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Gastrointestinal necrosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Gingival hyperplasia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Haematemesis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Haematochezia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Hiatus hernia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Ileus	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Inflammatory bowel disease	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Inguinal hernia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Intestinal obstruction	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Intestinal perforation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Intussusception	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Malabsorption	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Malocclusion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Nausea	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 8/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.14% 3/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Oral disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Pancreatitis	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Pancreatitis acute	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Pancreatitis relapsing	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Proctitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Protein-losing gastroenteropathy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Retroperitoneal haematoma	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Short-bowel syndrome	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Tooth discolouration	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Varices oesophageal	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Vomiting	0.05% 15/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.31% 29/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 4/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.23% 5/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.11% 9/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Asthenia	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Brain death	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Calcinosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Chest pain	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Crepitations	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Cyst	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Death	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.11% 10/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.11% 9/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Decreased activity	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Device failure	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Device malfunction	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Disease recurrence	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Drug ineffective	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Drug resistance	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Face oedema	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Fatigue	0.02% 6/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.12% 11/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Feeling abnormal	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Gait disturbance	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 8/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Hernia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Hunger	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Hyperthermia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Hypothermia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Influenza like illness	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site bruising	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site irritation	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site pain	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Liquid product physical issue	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Local swelling	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders No therapeutic response	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Non-cardiac chest pain	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Oedema	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Oedema peripheral	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 3/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Pain	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Peripheral swelling	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Pseudocyst	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Pyrexia	0.04% 12/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.19% 18/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.19% 4/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.14% 11/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Sluggishness	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Sudden cardiac death	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Sudden death	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Temperature intolerance	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Therapeutic response decreased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Thirst	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Xerosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Hepatobiliary disorders Cholecystitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Hepatobiliary disorders Cholelithiasis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Hepatobiliary disorders Chronic hepatic failure	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Hepatobiliary disorders Hepatic failure	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Hepatobiliary disorders Hepatic haematoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Hepatobiliary disorders Hepatic necrosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Hepatobiliary disorders Hepatitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Hepatobiliary disorders Hepatosplenomegaly	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Hepatobiliary disorders Jaundice	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Hepatobiliary disorders Liver disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Hepatobiliary disorders Portal hypertension	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Immune system disorders Acute graft versus host disease	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Immune system disorders Anaphylactic reaction	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Immune system disorders Anaphylactoid reaction	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Immune system disorders Graft versus host disease	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Immune system disorders Hypersensitivity	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Immune system disorders Immune system disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Immune system disorders Kidney transplant rejection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.89% 19/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Immune system disorders Liver transplant rejection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Immune system disorders Lung transplant rejection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Immune system disorders Sarcoidosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Immune system disorders Seasonal allergy	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Immune system disorders Transplant rejection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Abscess	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Acute sinusitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Appendicitis	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Arthritis bacterial	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Atypical pneumonia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Bronchitis	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Cellulitis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Colostomy infection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Conjunctivitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Croup infectious	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Cystitis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Device related infection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Device related sepsis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Disseminated cytomegaloviral infection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Ear infection	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Empyema	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Encephalitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Epstein-Barr virus infection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Eye infection viral	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Fungal infection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Fungal peritonitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Gastroenteritis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Gastroenteritis viral	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Helicobacter infection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Herpes simplex pharyngitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Herpes zoster	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Herpes zoster disseminated	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Impetigo	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Infected cyst	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Infection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Infection parasitic	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Infectious mononucleosis	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Infectious pleural effusion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Influenza	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 6/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Liver abscess	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Lung abscess	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Lung infection	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Lyme disease	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Mastoiditis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Meningitis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Meningitis viral	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Mucosal infection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Nasopharyngitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Orchitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Osteomyelitis	0.02% 5/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Otitis media	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Otitis media acute	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Otitis media chronic	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Peritonitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.37% 8/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Pharyngitis streptococcal	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Pneumonia	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.17% 16/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.14% 11/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Pneumonia bacterial	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Pneumonia streptococcal	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Post procedural infection	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Pseudomonas infection	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Pyelonephritis	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Respiratory tract infection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Scarlet fever	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Sepsis	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 7/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.19% 4/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Septic arthritis staphylococcal	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Septic shock	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.19% 4/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Shigella infection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Shunt infection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Sinusitis	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Staphylococcal sepsis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Streptococcal infection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Systemic infection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Systemic mycosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Tonsillitis	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Tonsillitis streptococcal	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Upper respiratory tract infection	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Urinary tract infection	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Varicella	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Viraemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Viral infection	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Ankle fracture	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Brain herniation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Complications of bone marrow transplant	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Complications of transplant surgery	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Complications of transplanted liver	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Concussion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Contusion	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Corneal abrasion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Drug administration error	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Drug dose omission	0.02% 6/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Epiphyseal fracture	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Extradural haematoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Eye injury	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Fall	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Femur fracture	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Foot fracture	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Foreign body	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Fracture	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Hand fracture	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Head injury	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Heat stroke	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 3/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Injury	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Joint dislocation	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Laceration	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Ligament rupture	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Metal poisoning	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Off label use	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Overdose	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Pneumothorax traumatic	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Postoperative adhesion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Radiation injury	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Radius fracture	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Road traffic accident	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Scar	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Shunt malfunction	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Sports injury	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Stoma site erythema	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Tibia fracture	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Ulna fracture	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Upper limb fracture	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Wrist fracture	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Ammonia increased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Antinuclear antibody positive	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Bleeding time prolonged	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood alcohol increased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood bilirubin increased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood creatinine increased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.37% 8/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood electrolytes abnormal	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood follicle stimulating hormone increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood glucose decreased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood glucose increased	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood gonadotrophin increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood parathyroid hormone increased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood pressure increased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood sodium decreased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood sodium increased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood testosterone increased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood urine	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Body height below normal	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Body temperature decreased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Body temperature increased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Bone density decreased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Breath sounds abnormal	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Cardiac murmur	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Cardiac output decreased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Culture positive	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Ejection fraction decreased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Electrocardiogram change	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Haemoglobin decreased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Heart rate decreased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Heart rate increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Heart sounds abnormal	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Hepatic enzyme increased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Insulin-like growth factor decreased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Insulin-like growth factor increased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Lipids increased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Liver function test abnormal	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Male genital examination abnormal	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Myocardial necrosis marker increased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Oxygen saturation decreased	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Platelet count increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Prothrombin time prolonged	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Pulmonary function test decreased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Red blood cells urine	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Rheumatoid factor	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Urine output decreased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Weight decreased	0.03% 7/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 5/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Weight increased	0.02% 5/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations White blood cell count decreased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Abnormal weight gain	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Acidosis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Cachexia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Decreased appetite	0.02% 5/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 7/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Dehydration	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.14% 13/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.14% 3/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Diabetes mellitus	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 6/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 3/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Fluid retention	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Haemochromatosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.19% 4/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Hypoglycaemia	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.20% 19/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 6/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Increased appetite	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Insulin resistance	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Ketoacidosis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Malnutrition	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.14% 3/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Obesity	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Overweight	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Polydipsia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Tetany	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 4/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 5/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Weight gain poor	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Arthralgia	0.05% 13/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 6/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Arthritis reactive	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Axillary mass	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Back pain	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Bone cyst	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Bone deformity	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Bone development abnormal	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Bone disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Chondropathy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Clubbing	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Epiphyseal disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Epiphysiolysis	0.06% 17/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.30% 28/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.12% 7/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 9/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.12% 10/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Growth retardation	0.03% 8/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Joint contracture	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Joint hyperextension	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Juvenile idiopathic arthritis	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Knee deformity	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Kyphoscoliosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Kyphosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Lordosis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Lower extremity mass	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Mixed connective tissue disease	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Muscle atrophy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Myalgia	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Neck mass	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Osteitis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.02% 5/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 4/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 5/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Osteolysis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Pain in extremity	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Renal osteodystrophy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Rickets	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Scoliosis	0.08% 22/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.17% 16/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 5/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.25% 14/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.26% 21/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Sever's disease	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Spondylitis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders VIth nerve paralysis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Torticollis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Winged scapula	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.12% 11/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal adenoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anaplastic astrocytoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiofibroma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiosarcoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Astrocytoma	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.34% 32/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.11% 10/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain stem glioma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Burkitt's lymphoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Central nervous system neoplasm	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chondrosarcoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Craniopharyngioma	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.80% 75/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Dysplastic naevus	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ependymoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Erythroleukaemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroadenoma of breast	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroma	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibrosarcoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Focal nodular hyperplasia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ganglioneuroma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Germ cell cancer	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 7/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Giant cell tumour of tendon sheath	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioma	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 8/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioneuronal tumour	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic adenoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatoblastoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Histiocytosis	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 8/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease recurrent	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papilloma of breast	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Langerhans' cell histiocytosis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia recurrent	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangioma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoproliferative disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant fibrous histiocytoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of spinal cord	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medulloblastoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medulloblastoma recurrent	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.30% 28/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to skin	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to the mediastinum	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Monoclonal gammopathy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloid leukaemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm recurrence	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nephroblastoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroblastoma	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neurofibroma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neurofibrosarcoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oligodendroglioma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Optic glioma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 7/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oral neoplasm	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Osteochondroma	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Osteoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Osteosarcoma	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 6/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Osteosarcoma recurrent	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian dysgerminoma stage unspecified	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian germ cell cancer	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Phaeochromocytoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pineal neoplasm	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pinealoblastoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.02% 5/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 8/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Post transplant lymphoproliferative disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Primitive neuroectodermal tumour	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prolactinoma	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pyogenic granuloma	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rhabdomyosarcoma recurrent	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Schwannoma	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seminoma	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T-cell lymphoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Teratoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testicular embryonal carcinoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testicular germ cell cancer	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid adenoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval neoplasm	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Amnesia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Aphasia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Arachnoid cyst	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Ataxia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Autism	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Balance disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Benign intracranial hypertension	0.04% 11/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 4/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.47% 10/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.10% 8/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Benign rolandic epilepsy	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Brain mass	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Brain oedema	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Brain stem haemorrhage	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Brain stem syndrome	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Carpal tunnel syndrome	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Central nervous system inflammation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Cerebral cyst	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Cerebral haemorrhage	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Cerebral infarction	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Cerebral ventricle dilatation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Cerebrovascular accident	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 5/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Clonic convulsion	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Coma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Complex partial seizures	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Complex regional pain syndrome	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Cranial nerve palsies multiple	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Demyelination	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Depressed level of consciousness	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Diabetic hyperosmolar coma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Disturbance in attention	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Dizziness	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Dysarthria	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Dysstasia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Encephalopathy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Epilepsy	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Generalised tonic-clonic seizure	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 5/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Guillain-Barre syndrome	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Haemorrhage intracranial	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Headache	0.06% 17/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.34% 32/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 6/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 5/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.28% 6/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.11% 9/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Hemiparesis	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Hemiplegia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Hydrocephalus	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Hypertensive encephalopathy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Hypertonia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Hypoaesthesia	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Hypoglycaemic coma	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Hypoglycaemic seizure	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Hyponatraemic seizure	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Hypotonia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Intracranial aneurysm	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Intracranial pressure increased	0.04% 12/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 6/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Intraventricular haemorrhage	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Ischaemic stroke	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Lethargy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 6/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Loss of consciousness	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Memory impairment	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Migraine	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Multiple sclerosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Muscle spasticity	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Myoclonic epilepsy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Nerve compression	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Nervous system disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Neuralgia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Neurodegenerative disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Neurological decompensation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Nystagmus	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Optic neuritis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Paraesthesia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Paralysis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Paraplegia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Petit mal epilepsy	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Psychomotor hyperactivity	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Sciatic nerve neuropathy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Seizure	0.05% 15/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.48% 45/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 4/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.14% 11/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Sensory loss	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Somnolence	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Speech disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Spinal cord compression	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Spinocerebellar disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Status epilepticus	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Subarachnoid haemorrhage	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Syncope	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Tremor	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders VIIth nerve paralysis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Vasculitis cerebral	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Visual field defect	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Abnormal behaviour	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Acute psychosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Adjustment disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Aggression	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Alcohol abuse	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Anger	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Anorexia nervosa	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Anxiety	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Attention deficit/hyperactivity disorder	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Bipolar disorder	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Completed suicide	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Confusional state	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Delirium	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Delusion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Depression	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 5/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Disorientation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Drug abuse	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Emotional disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Emotional distress	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Hallucination, auditory	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Hostility	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Inappropriate affect	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Insomnia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Irritability	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Libido decreased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Listless	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Mental disorder	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Mental status changes	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Mood swings	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Schizophrenia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Schizophreniform disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Staring	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Stress	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Suicidal ideation	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Suicide attempt	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Acute kidney injury	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Azotaemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Bladder spasm	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Chronic kidney disease	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.23% 5/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Dysuria	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Enuresis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Glomerulonephritis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Glomerulonephritis membranoproliferative	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Glycosuria	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Haematuria	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Hydronephrosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Hypercalciuria	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders IgA nephropathy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Incontinence	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Ketonuria	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Lupus nephritis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Nephritis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Nephrolithiasis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Nocturia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Polyuria	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Renal cyst	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Renal disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Renal failure	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.33% 7/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Renal impairment	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Urethral obstruction	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Urinary incontinence	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Urine abnormality	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Amenorrhoea	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Galactocele	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Galactorrhoea	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Gynaecomastia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Menstruation irregular	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Ovarian cyst ruptured	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Testicular atrophy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Testicular disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Testicular torsion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Varicocele	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Asthma	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Bronchial secretion retention	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Cough	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 5/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Hypopnoea	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Hypoventilation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Pharyngeal disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 5/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.14% 3/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Respiratory symptom	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Rhonchi	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Snoring	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Status asthmaticus	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Upper airway obstruction	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Wheezing	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Acanthosis nigricans	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Acne	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Blister	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Dermatitis exfoliative	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Dry skin	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Erythema	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Excessive granulation tissue	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Hair growth abnormal	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Hirsutism	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Hypertrichosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Rash	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Scab	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Telangiectasia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Urticaria	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Social circumstances Walking disability	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Surgical and medical procedures Appendicectomy	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Surgical and medical procedures Cholecystectomy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Surgical and medical procedures Cleft lip repair	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Surgical and medical procedures Hip surgery	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Surgical and medical procedures Limb operation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Surgical and medical procedures Renal transplant	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Surgical and medical procedures Spinal fusion surgery	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Surgical and medical procedures Talipes correction	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Aortic aneurysm	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Aortic aneurysm rupture	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Aortic dilatation	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Aortic dissection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Aortic stenosis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Arterial rupture	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Deep vein thrombosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Haemorrhage	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Hypertension	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 4/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 9/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Hypotension	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 7/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Internal haemorrhage	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Kawasaki's disease	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Lymphoedema	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Pallor	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Superior mesenteric artery syndrome	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Thrombosis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Neurofibromatosis	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Proteinuria	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.14% 3/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.

Other adverse events

Other adverse events
Measure	Idiopathic Growth Hormone Deficiency (IGHD) n=27286 participants at risk Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.	Organic GHD n=9356 participants at risk Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.	Idiopathic Short Stature (ISS) n=12519 participants at risk Participants must have had a stimulation result of \>/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of \>/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of \>/=10 ng/mL.	Turner Syndrome n=5651 participants at risk Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.	Renal Disease n=2144 participants at risk Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.	Other Etiology n=8010 participants at risk The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.	Undefined Etiology n=239 participants at risk A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
Ear and labyrinth disorders Cerumen impaction	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Ear and labyrinth disorders Deafness	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 3/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Anaemia	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Increased tendency to bruise	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Leukopenia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Lymph node pain	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Lymphadenopathy	0.03% 9/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Neutropenia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Splenomegaly	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Aortic valve incompetence	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Arrhythmia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Cardiac flutter	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Cardiomyopathy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Cyanosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Extrasystoles	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Left ventricular dysfunction	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Mitral valve incompetence	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Mitral valve prolapse	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Palpitations	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Pericardial effusion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Supravalvular aortic stenosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Tachycardia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Tricuspid valve incompetence	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Ventricular hypertrophy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Cardiac disorders Wolff-Parkinson-White syndrome	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Basal cell naevus syndrome	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Carpus curvus	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Clinodactyly	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Congenital anaemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Congenital aplastic anaemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Congenital nail disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Cryptorchism	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Dysmorphism	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Dysplastic naevus syndrome	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Fanconi syndrome	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Angiopathy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Femoral anteversion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Fibrous dysplasia of bone	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Gilbert's syndrome	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Hamartoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Hemihypertrophy	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Micrognathia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Mitochondrial myopathy	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Muscular dystrophy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Myotonia congenita	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Neurofibromatosis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Pectus carinatum	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Pectus excavatum	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Pterygium colli	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Skeletal dysplasia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Syringomyelia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Congenital, familial and genetic disorders Tourette's disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Ear and labyrinth disorders Ear discomfort	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Ear and labyrinth disorders Ear disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Ear and labyrinth disorders Ear pain	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Ear and labyrinth disorders Hearing impaired	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Ear and labyrinth disorders Hypoacusis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Ear and labyrinth disorders Middle ear effusion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Ear and labyrinth disorders Otorrhoea	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Ear and labyrinth disorders Tinnitus	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 3/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Acromegaly	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 4/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Adrenal insufficiency	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Adrenal suppression	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Adrenocorticotropic hormone deficiency	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Autoimmune thyroiditis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Basedow's disease	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Cushingoid	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Delayed puberty	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Diabetes insipidus	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Early menarche	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Endocrine disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Goitre	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Growth accelerated	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Growth hormone deficiency	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Hyperprolactinaemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Hyperthyroidism	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Hypothyroidism	0.03% 9/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Pituitary cyst	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Precocious puberty	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Testicular failure	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Endocrine disorders Thyroid disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Asthenopia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Astigmatism	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Blindness	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Blindness transient	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Cataract	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Conjunctival hyperaemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Dark circles under eyes	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Diplopia	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Dry eye	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Excessive eye blinking	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Exophthalmos	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Eye disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Eye oedema	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Eye pain	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Eye pruritus	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Eye swelling	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Eyelid oedema	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Eyelid ptosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Eyelid skin dryness	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Glaucoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Iritis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Lacrimation increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Myopia	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Night blindness	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Ocular hyperaemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Ocular icterus	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Ocular myasthenia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Ocular vascular disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Optic atrophy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Optic disc disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Optic discs blurred	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Panophthalmitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Papilloedema	0.02% 5/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Periorbital oedema	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Photophobia	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Pseudopapilloedema	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Retinal disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Retinal pigmentation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Strabismus	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Ulcerative keratitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Vision blurred	0.04% 12/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 5/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 3/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Visual acuity reduced	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 5/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Eye disorders Visual impairment	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 5/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Abdominal distension	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Abdominal mass	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Abdominal pain	0.04% 11/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 5/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 6/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.16% 9/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 7/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Abdominal pain lower	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Abdominal pain upper	0.04% 11/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 4/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 5/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Breath odour	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Coeliac disease	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Constipation	0.03% 9/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 5/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Crohn's disease	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Dental caries	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Diarrhoea	0.03% 9/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 6/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.12% 7/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Dry mouth	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Faecal incontinence	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Faecaloma	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Faeces hard	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Flatulence	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Gastric disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Gastric ulcer	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Gastritis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Gastrointestinal motility disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Glossodynia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Haematochezia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Inflammatory bowel disease	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Infrequent bowel movements	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Intestinal stenosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Large intestine polyp	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Lip swelling	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Loose tooth	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Malocclusion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Nausea	0.06% 16/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.16% 15/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.11% 6/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Oesophagitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Painful defaecation	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Palatal disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Pancreatitis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Parotid gland enlargement	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Rectal discharge	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Swollen tongue	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Tooth demineralisation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Tooth deposit	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Tooth development disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Tooth discolouration	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Tooth loss	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Tooth resorption	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Gastrointestinal disorders Vomiting	0.11% 31/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.19% 18/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 8/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.21% 12/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.14% 3/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 6/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Adverse event	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Application site discomfort	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Asthenia	0.03% 7/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 8/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Calcinosis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Chest discomfort	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Chest pain	0.03% 8/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 3/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Chills	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Chronic fatigue syndrome	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Crying	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Cyst	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Decreased activity	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Developmental delay	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Device defective	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Device issue	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Discomfort	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Drug effect decreased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Drug ineffective	0.05% 14/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.11% 10/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 7/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.27% 15/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.22% 18/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Drug interaction	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Drug intolerance	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Drug resistance	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Energy increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Exercise tolerance decreased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Face oedema	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Facial pain	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Fat tissue increased	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Fatigue	0.07% 20/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.21% 20/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 9/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.11% 6/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 5/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Feeling abnormal	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Feeling cold	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Feeling hot	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Feeling of body temperature change	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Gait disturbance	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders General physical health deterioration	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Generalised oedema	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Hernia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Hunger	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Hypertrophy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Hypothermia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Ill-defined disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Impaired healing	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Inflammation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Influenza like illness	0.02% 5/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site atrophy	0.04% 11/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 5/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site bruising	0.04% 11/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 6/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.11% 6/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.10% 8/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Hepatobiliary disorders Hepatomegaly	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site discolouration	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site discomfort	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site erythema	0.03% 7/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 3/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site extravasation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site haematoma	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site haemorrhage	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site hypertrophy	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site induration	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site inflammation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site mass	0.02% 5/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site nodule	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site pain	0.31% 85/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.30% 28/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.26% 33/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.16% 9/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.33% 7/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.26% 21/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.84% 2/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site pruritus	0.02% 6/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site rash	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site reaction	0.02% 6/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 4/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 3/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site swelling	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site urticaria	0.03% 7/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 5/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site vesicles	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Injection site warmth	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Malaise	0.04% 11/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.12% 11/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Mass	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Medical device complication	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Medical device discomfort	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Medical device pain	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Mucous membrane disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders No adverse event	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders No therapeutic response	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Nodule	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Oedema	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 7/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.11% 6/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Oedema peripheral	0.03% 7/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.10% 9/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.19% 11/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 5/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Pain	0.04% 12/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 4/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 6/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Peripheral swelling	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 7/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 5/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Product odour abnormal	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Product quality issue	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Pyrexia	0.08% 21/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.11% 10/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 4/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 4/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.12% 10/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Sluggishness	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Swelling	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Temperature intolerance	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Tenderness	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Therapeutic response decreased	0.02% 5/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Thirst	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Unevaluable event	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
General disorders Vaccination site reaction	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Hepatobiliary disorders Cholelithiasis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Hepatobiliary disorders Hepatic failure	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Hepatobiliary disorders Hepatitis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Hepatobiliary disorders Jaundice	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Immune system disorders Anaphylactic reaction	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Immune system disorders Drug hypersensitivity	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Immune system disorders Hypersensitivity	0.04% 10/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Immune system disorders Hypogammaglobulinaemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Immune system disorders Kidney transplant rejection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Immune system disorders Multiple chemical sensitivity	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Immune system disorders Rubber sensitivity	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Immune system disorders Seasonal allergy	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Immune system disorders Transplant rejection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Abscess limb	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Acarodermatitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Acne pustular	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Adenoiditis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Appendicitis perforated	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Application site folliculitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Bronchitis	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Cat scratch disease	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Cellulitis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Chronic sinusitis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Conjunctivitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Croup infectious	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Device related infection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Ear infection	0.04% 10/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.19% 11/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Epididymitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Fungal skin infection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Furuncle	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Gastroenteritis	0.02% 6/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Gastroenteritis viral	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 4/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Gastrointestinal viral infection	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Gingivitis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Hepatitis A	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Hepatitis C	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Herpes virus infection	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Herpes zoster	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Impetigo	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Infection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Infectious mononucleosis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Influenza	0.03% 7/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Injection site abscess	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Localised infection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Lower respiratory tract infection	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Lyme disease	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Meningitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Meningitis aseptic	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Molluscum contagiosum	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Nasopharyngitis	0.04% 10/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 5/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 3/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Onychomycosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Oral herpes	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Otitis externa	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Otitis media	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.14% 8/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Otitis media acute	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Otitis media chronic	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Pharyngitis	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Pharyngitis streptococcal	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 4/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Pneumonia	0.02% 5/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Rash pustular	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Respiratory tract infection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Scarlet fever	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Sinusitis	0.04% 12/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.12% 7/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.14% 3/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Tinea versicolour	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Tonsillitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Tooth abscess	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Upper respiratory tract infection	0.02% 5/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.11% 6/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Urinary tract infection	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 5/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Varicella	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Viral infection	0.02% 5/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 3/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Viral rash	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Accident	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Accidental exposure to product	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Accidental overdose	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Ankle fracture	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Clavicle fracture	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Drug administration error	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Concussion	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Contusion	0.03% 7/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 5/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 3/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Drug dose omission	0.19% 53/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.10% 9/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.13% 16/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.23% 13/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.14% 11/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Ear canal abrasion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Epiphyseal fracture	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Excoriation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Extra dose administered	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Fall	0.02% 6/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Fibula fracture	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Foot fracture	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Fracture	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Hand fracture	0.02% 5/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Head injury	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Incorrect dose administered	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Injury	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Joint dislocation	0.02% 5/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Joint injury	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Laceration	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Ligament sprain	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Lower limb fracture	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Medication error	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Muscle strain	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Off label use	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Overdose	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Patella fracture	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Product preparation error	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Radius fracture	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Scar	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Sports injury	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Stress fracture	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Thermal burn	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Tibia fracture	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Ulna fracture	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Underdose	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Upper limb fracture	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Injury, poisoning and procedural complications Wrist fracture	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Alanine aminotransferase increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Antibody test positive	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Anti-islet cell antibody positive	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Aspartate aminotransferase increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Bleeding time prolonged	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood alkaline phosphatase increased	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood bilirubin increased	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood calcium increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood cholesterol abnormal	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood cholesterol increased	0.02% 6/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood corticotrophin decreased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood creatine phosphokinase increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood creatinine increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.56% 12/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood follicle stimulating hormone increased	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood glucose abnormal	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood glucose decreased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood glucose increased	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood gonadotrophin decreased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood lactate dehydrogenase increased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood luteinising hormone increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood parathyroid hormone increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood phosphorus increased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood pressure abnormal	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood pressure decreased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood pressure increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 3/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood pressure systolic increased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood prolactin increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood thyroid stimulating hormone abnormal	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood thyroid stimulating hormone decreased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood triglycerides increased	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood urea decreased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood urea increased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood urea nitrogen/creatinine ratio increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Blood urine present	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Body height below normal	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Body temperature increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Bone density decreased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Breath sounds abnormal	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Cardiac murmur	0.02% 6/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 5/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Electrocardiogram QT prolonged	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Eosinophil count decreased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Gamma-glutamyltransferase increased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Glucose tolerance test abnormal	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Glucose urine	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Glycosylated haemoglobin increased	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Haematocrit decreased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Haemoglobin decreased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Heart rate decreased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Heart rate increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Hepatic enzyme abnormal	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Hepatic enzyme increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Insulin-like growth factor decreased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 7/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Insulin-like growth factor increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Intelligence test abnormal	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Intraocular pressure increased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Laboratory test abnormal	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Lipids abnormal	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Lipids increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Liver function test abnormal	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Low density lipoprotein increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Lymphocyte count decreased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Mean cell haemoglobin increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Mean cell volume decreased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Mean cell volume increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Neutrophil count decreased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Oxygen saturation decreased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Pancreatic enzymes increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Platelet count decreased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Platelet count increased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Protein urine	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Red blood cell sedimentation rate increased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Thyroxine decreased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Thyroxine free	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Urine output increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Waist circumference increased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Weight decreased	0.05% 14/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 6/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 5/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 4/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 5/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations Weight increased	0.04% 12/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.13% 12/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 4/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 4/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 7/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations White blood cell count decreased	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Cerebrovascular accident	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations White blood cell count increased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Investigations White blood cells urine positive	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Abnormal weight gain	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Appetite disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Body fat disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Carbohydrate intolerance	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Decreased appetite	0.04% 11/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 7/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 7/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Dehydration	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Diabetes mellitus	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Failure to thrive	0.15% 42/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.44% 41/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.33% 41/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.57% 32/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 9/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.50% 40/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Fat intolerance	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Fluid overload	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Fluid retention	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 6/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Hypercholesterolaemia	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Hyperglycaemia	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.10% 9/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 7/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Hyperinsulinaemia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Hyperphagia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Hypoglycaemia	0.05% 13/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.15% 14/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Hypokalaemia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Increased appetite	0.02% 5/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Insulin resistance	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Ketosis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Lack of satiety	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Lipid metabolism disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Obesity	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Overweight	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Polydipsia	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Underweight	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Metabolism and nutrition disorders Weight gain poor	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Arthralgia	0.24% 66/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.34% 32/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.16% 20/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.30% 17/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.14% 3/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.20% 16/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Arthropathy	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Back pain	0.04% 10/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 7/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 6/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.11% 6/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Bone deformity	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Bone development abnormal	0.03% 9/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 5/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 4/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 4/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Bone disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Bone lesion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Bone pain	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Clubbing	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Coccydynia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Diastasis recti abdominis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Epiphyseal disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Epiphyses delayed fusion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Epiphyses premature fusion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Epiphysiolysis	0.02% 5/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 7/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 3/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Epiphysitis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Exostosis	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 5/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Finger deformity	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Growing pains	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Growth retardation	0.11% 30/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.18% 17/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.14% 18/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.16% 9/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.14% 3/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.12% 10/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Inguinal mass	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Joint crepitation	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Joint instability	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Joint swelling	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 4/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Knee deformity	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.14% 3/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Kyphosis	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Ligament pain	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Limb asymmetry	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Limb discomfort	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Lordosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Lumbar spine flattening	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Muscle atrophy	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Muscle disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Muscle rigidity	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Muscular weakness	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Myalgia	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Neck mass	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.10% 26/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 5/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 7/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Osteolysis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.14% 3/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Osteoporosis	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Pain in extremity	0.10% 27/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.13% 12/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 11/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 3/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 5/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Prognathism	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Renal osteodystrophy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Rib deformity	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Rickets	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Scoliosis	0.18% 48/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.34% 32/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.20% 25/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.53% 30/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.14% 3/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.37% 30/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Sever's disease	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Soft tissue disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Soft tissue swelling	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Spinal deformity	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Spondylolysis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Synovial cyst	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Flushing	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acrochordon	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Astrocytoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone giant cell tumour benign	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone neoplasm	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Craniopharyngioma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 5/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Enchondromatosis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ependymoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroma	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Germ cell cancer	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Histiocytosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Juvenile melanoma benign	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medulloblastoma recurrent	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.03% 9/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 7/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 4/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.23% 13/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm recurrence	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neurofibroma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ocular neoplasm	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Osteochondroma	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Osteoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pyogenic granuloma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Amnesia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Arachnoiditis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Areflexia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Balance disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Benign intracranial hypertension	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 3/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Burning sensation	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Carpal tunnel syndrome	0.03% 7/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Central nervous system lesion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Chorea	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Choreoathetosis	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Cluster headache	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Cognitive disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Dementia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Disturbance in attention	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Dizziness	0.05% 15/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 6/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 3/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Dizziness postural	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Dysarthria	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Dyskinesia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Febrile convulsion	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Generalised tonic-clonic seizure	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Head discomfort	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Headache	0.47% 128/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.77% 72/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.30% 38/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.60% 34/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.37% 8/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.36% 29/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Hemiparesis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Hydrocephalus	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Hyperaesthesia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Hyperreflexia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Hypersomnia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Hypertonia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Hypoaesthesia	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Hypoglycaemic seizure	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Hypotonia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Intracranial pressure increased	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 5/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Judgement impaired	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Lethargy	0.02% 5/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Loss of consciousness	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Memory impairment	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Migraine	0.04% 12/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 3/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Motor dysfunction	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Muscle contractions involuntary	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Muscle spasticity	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Myoclonic epilepsy	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Nervous system disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Neuromyopathy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Nystagmus	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Paraesthesia	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Partial seizures	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Petit mal epilepsy	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Poor quality sleep	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Presyncope	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Psychomotor hyperactivity	0.03% 8/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Seizure	0.05% 15/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.25% 23/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 4/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Sensory disturbance	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Sinus headache	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Slow response to stimuli	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Slow speech	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Somnolence	0.03% 7/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Speech disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Speech disorder developmental	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Costovertebral angle tenderness	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Stupor	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Syncope	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Dysuria	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Temporal lobe epilepsy	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Tremor	0.02% 6/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Tunnel vision	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders VIIth nerve paralysis	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 3/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Nervous system disorders Visual field defect	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Abnormal behaviour	0.02% 6/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 6/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Affect lability	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Aggression	0.02% 5/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Agitation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Anger	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Anorexia nervosa	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Anticipatory anxiety	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Anxiety	0.02% 5/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Anxiety disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Asocial behaviour	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Attention deficit/hyperactivity disorder	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Bipolar disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Compulsions	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Confusional state	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Depression	0.04% 11/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 5/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Depression suicidal	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Dysphemia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Eating disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Emotional disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Emotional distress	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Encopresis	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Frustration	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Hostility	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Hypomania	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Initial insomnia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Insomnia	0.03% 8/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Irritability	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Mood altered	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Mood swings	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Negativism	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Nightmare	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Reading disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Restlessness	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Sleep disorder	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Somatoform disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Staring	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Stress	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Suicidal ideation	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Suicide attempt	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Tension	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Psychiatric disorders Tic	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Chromaturia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Enuresis	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Glomerulonephritis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Glomerulonephritis acute	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Glycosuria	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Haematuria	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Micturition disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Nephrolithiasis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Nocturia	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Oliguria	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Pollakiuria	0.02% 5/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Polyuria	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 7/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Proteinuria	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Renal failure	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.23% 5/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Renal impairment	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Urinary incontinence	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Urinary retention	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Amenorrhoea	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Bilateral breast buds	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Breast cyst	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Breast discomfort	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Breast enlargement	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Breast mass	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Breast pain	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Breast swelling	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Breast tenderness	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Enlarged clitoris	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Genital rash	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Gynaecomastia	0.12% 33/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 7/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.10% 12/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 7/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Menorrhagia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Menstruation irregular	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Nipple pain	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Ovarian failure	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Penile swelling	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Scrotal erythema	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Scrotal oedema	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Testicular disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Testicular mass	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Testicular pain	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Testicular torsion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 4/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Reproductive system and breast disorders Varicocele	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Allergic sinusitis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Asthma	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 3/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Asthma exercise induced	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Cough	0.02% 6/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 8/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 4/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 6/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Nasal mucosal disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Nasal pruritus	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.03% 8/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Pharyngeal disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Prolonged expiration	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Sneezing	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Snoring	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Sputum discoloured	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Status asthmaticus	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 4/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Acanthosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Acanthosis nigricans	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Acne	0.05% 13/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 5/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 7/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.42% 1/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Alopecia	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 5/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Alopecia areata	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Blister	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Cafe au lait spots	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Dermatitis contact	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Dry skin	0.05% 14/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.13% 12/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 3/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.14% 8/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Eczema	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 3/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Ephelides	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Erythema	0.02% 5/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Haematoma	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Erythema multiforme	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Hair disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Hair growth abnormal	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Hair texture abnormal	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Hirsutism	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.01% 3/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Hypertrichosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Hypotrichosis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Ingrowing nail	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Keloid scar	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Koilonychia	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Lentigo	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Lipoatrophy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Macule	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Madarosis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Miliaria	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Nail dystrophy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.03% 3/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Papule	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Petechiae	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Pigmentation disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Pityriasis rosea	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Pruritus	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 4/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Pruritus generalised	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Purpura	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Rash	0.07% 19/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 7/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 9/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.11% 6/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 5/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Rash follicular	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Rash papular	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Rash pruritic	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 1/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Seborrhoea	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Skin atrophy	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Skin odour abnormal	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Skin striae	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Skin tightness	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Skin wrinkling	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Swelling face	0.01% 4/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 2/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.04% 3/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Telangiectasia	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Trichorrhexis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Skin and subcutaneous tissue disorders Urticaria	0.08% 23/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.06% 6/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.05% 6/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 5/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Social circumstances Activities of daily living impaired	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Social circumstances Premenarche	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Social circumstances Treatment noncompliance	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Surgical and medical procedures Suture insertion	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Hot flush	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Hypertension	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.12% 7/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.09% 2/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Lymphoedema	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.07% 4/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Orthostatic hypotension	0.01% 2/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Pallor	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Raynaud's phenomenon	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.01% 1/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Systolic hypertension	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Varicose vein	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Vasculitis	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 2/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Vascular disorders Vein disorder	0.00% 1/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.
Renal and urinary disorders Vesicoureteric reflux	0.00% 0/27286 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/9356 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/12519 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.02% 1/5651 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/2144 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/8010 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.	0.00% 0/239 • From October 1985 to June 2010 (overall approximately 24 years and 9 months) Protocol-mandated adverse events (AEs): all treatment-related AEs, all serious adverse events (SAEs), and all protocol-defined adverse events of special interest (AESIs) were reported.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER